Cleared Traditional

K002069 - ASCEND SPINAL FIXATION SYSTEM

K002069 is an FDA 510(k) clearance for ASCEND SPINAL FIXATION SYSTEM, manufactured by Spinal Innovations, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K002069 · Spinal Innovations, LLC · Orthopedic device
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Oct 2000
Decision
90d
Days
Class 2
Risk

K002069 is an FDA 510(k) clearance for the ASCEND SPINAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Spinal Innovations, LLC (Bartlett, US). The FDA issued a Cleared decision on October 5, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Spinal Innovations, LLC devices

FDA 510(k) Submission Details - K002069

510(k) Number K002069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2000
Decision Date October 05, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 368
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K002069.
SIMPLICITY SPINAL SYSTEM
K002103 · Medtronic Sofamor Danek USA, Inc. · Nov 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K002959 · Encore Orthopedics, Inc. · Oct 2000
SPEEDLINK TRANSVERSE CONNECTOR
K002082 · Spinal Concepts, Inc. · Oct 2000
XIA SPINE SYSTEM
K002505 · Howmedica Osteonics Corp. · Oct 2000
USS VAS
K002517 · Synthes (Usa) · Sep 2000
MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS
K002607 · Depuyacromed · Sep 2000